Stem Cell Therapeutics (SCT) and Medicon have received approval to begin the Phase I clinical study in SCT's NTx-265 program for the treatment of stroke. The Danish Medicines Agency (DMA) and the Institutional Review Board (IRB) have both responded to the study protocol submission with written consent.
The trial is designed to characterize the pharmacokinetic profile of two currently marketed drugs, identified by SCT as effective in nonclinical models of stroke. Now that formal approval from the DMA and the IRB has been received, screening of volunteers who will serve as trial subjects will be initiated in the near future. Drug administration is expected to begin within 30 days of the first subject being screened. The study subjects will be dosed in two groups staggered by approximately two weeks. The duration of the trial is anticipated to be eight weeks.